Our client is a well-stablished and successful manufacturer, they are looking for Microbiology Manager to join the company, you will have the responsibility of assuring that microbiological quality control systems and activities, associated training, and environmental monitoring within the company are meeting cGMP regulation and guidelines.
In this role you are responsible for providing effective leadership within the microbiological laboratory. You are responsible for the proper functioning of the team and for an efficient and smooth flow of the analyses.
Salary: £50,000 + benefits (including 8% pension)
Hours of work: 8.00am – 4.00pm, Monday to Friday (every other Friday off)
PLEASE ONLY APPLY IF YOU MEET THE MAJORITY OF THESE REQUIREMENTS:
* Minimum of 3 years of relevant experience in a Pharmaceutical GMP quality control laboratory.
* Experience of managing a team, along with coaching and mentoring experience.
* BSc Hons in Microbiology or equivalent in a Scientific field or relevant experience.
* Strong knowledge of USP, EU, and ISO regulations is a must.
* Knowledge of Microbiological testing such as LAL, Membrane Filtration, bioburden, environmental monitoring, Dispersion, Use of a Microscope, Gram staining, Incubation of samples.
* Computer literate including Word and Excel.
* Excellent concise technical writing skills with attention to detail including formatting for clarity.
* Knowledge of environmental, health and safety, and regulatory standards.
* Prior experience with, writing protocols, data review, authoring SOPS, Change Controls, out-of-specification investigations, and report writing.
* Strong analytical and problem-solving skills.
To give you an overview of what the microbiological team do;
* Sample facilities and utilities using active air, settle plates, contact plates, swabs and rinses.
* Execute microbiological tests including (but not limited to):
* Water testing (LAL & Membrane filtration)
* Bioburden testing
* Environmental monitoring
* Dispersion testing using a microscope
* Perform analysis for process, product, cleaning and equipment validation studies
* Conduct analysis for stability studies and method transfer.
* Co-ordinate, prepare and dispatch samples to external laboratories for analysis.
* Mange third party laboratory results.
* Perform regular maintenance and minor repairs, keeping clean and calibrating equipment, materials and spaces.
* Manage inventory and orders of microbiological stock, consumer goods and parts of equipment.
Key Responsibilities:
- Leading, coaching, training and motivating Microbiologists as well as conducting PDR, development interviews, etc.
- Stay abreast of developments in the field through training, reading of literature, documentation and the like.
- Provide technical expertise to identify and facilitate the update of methodologies and best practices.
- Ensure microbiological best practices are adhered to for all site projects and in particular those which implement new equipment, technology, analytical methods, processes or materials.
- Stimulating safe working and continuous improvement of the quality culture.
- Support continuous improvement program throughout the company.
- Cross functional collaboration to ensure the day-to-day management of the departmental process, to ensure that common goals are met, plans are established and implemented, to meet product delivery requirements.
- Support the generation of resource plans.
- Participate in operational work meetings and internal quality meetings.
- Perform out-of-specification investigations, environmental excursion investigations and deviations per company procedures.
- Develop and validate testing methods used in routine analysis of incoming raw materials and finished products
- Assist in writing validation protocols, project reports, updating laboratory documentation, SOPs, and test methods.
- Provide strategic influence to the site to help ensure good practices are implemented and maintained in the manufacturing areas
- Provide microbiological expertise during the planning and introduction of new procedures, new products and process improvements
- Perform quality assessments on the microbiological performance related to utilities, HVAC, bioburden and environmental monitoring in support of batch release by the QP
- Lead the investigations on microbiology related excursions, and provide support to production, quality control and quality assurance groups during investigations
- Other special projects (i.e. Disinfectant Efficacy study)
- Approve of monthly microbiology and environmental monitoring trend reports of production areas and utilities
- Liaise with the QC microbiologists on the microbiological trending programme and corrective actions
- Devise and provide technical training and underpinning knowledge training to manufacturing and analytical departments to improve microbiological knowledge and understanding
- Represent the company at regulatory inspections (including FDA and MHRA) and respond to questions
- Prepare and review regulatory documentation (CMC) and respond to information requests from agencies
- All other tasks that can reasonably be requested and approved by the management.
- Ensure both your own health and safety and that of others, ensure that all company safety and quality systems and relevant legislation are complied with, ask questions and report any incidents or suggestions to the manager;
- Ensure that all waste is safely removed and is in line with business processes.
This role would suit someone with similar previous job titles such as; QC Microbiology Manager / Microbiological Manager / Microbiology Team Leader / Microbiology Supervisor / Lab Manager / Lab Team Leader / Lab Supervisor / Laboratory Manager / Laboratory Team Leader / Laboratory Supervisor / Pharmaceutical Quality Control Manager / Pharmaceutical Quality Assurance Manager / Microbiology Laboratory Manager / Operational Manager of Microbiology / Microbiology Shift Manager / Microbiology Technical Manager / Lead QC & Lab Operations / Scientific Manager / Microbiology Technical Specialist